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From reliable, non invasive evidence of low collateral ventilation...

SeleCT by VIDA provides clinicians a method to submit High Resolution CTs (HRCTs) and receive quantitativemeasurements to support visual readings of lung parenchyma that may be suitable for bronchial valvetreatment.

Advantages of quantitative measurements include:

More accurate and reproducible than visual CT analysis. 1

Comparable accuracy to Chartis. 1

Avoids an invasive procedure just to confirm collateral ventilation. 1

Not dependent on anatomy, coughing, or mucus where direct bronchoscopic measure may be unreliable or not possible. 1

Patient Selection for the Treatment of Emphysema with the Spiration Valve System

The selection criteria are based on clinical experience gathered to date on bronchial valve therapy and two peer-reviewed studies, including two similar emphysematous patient populations. The first study was sponsored by a grant from Olympus using the Spiration Valve System2, and the second sponsored by Pulmonx using the Zephyr® Endobronchial Valve.3 The highlighted evaluation factors below are some of the most important criteria for patient selection from the published literature.

Physicians should evaluate these studies and the selection criteria on their own. These recommendations are not meant to replace patient-specific clinical judgment, and may evolve with the release of new clinical study findings.

Patient Evaluation

Clinically studied patients have had:

FEV1 ≤ 45% predicted3

Residual Volume (RV) > 150% predicted2,3

Total Lung Capacity (TLC) > 100% predicted2,3

6MWD ≥ 150 m2,3

Hypercapnia with PaCO2 ≤ 50 mm Hg2,3

PaO2 > 45 mm Hg (6.0 kPa) on room air2

HRCT Scanning Parameters:

An HRCT scan is used to estimate the extent and distribution of emphysema and to identify whether there is a suitable treatment lobe that may respond favorably to Spiration Valve treatment. A suitable scanning protocol will include:

Image taken at full suspended inspiration4

1-1.25mm contiguous slices4,5

70-100 milliampere seconds (mAs)4,5

120 kVp4,5

512 x 512 slice matrices4

Perfusion Scanning:

Perfusion Scintigraphy may also be conducted to confirm heterogeneity and very low perfusion in the region of the target lobe selected for treatment.2,7

Identify Target Lobe for Treatment

1. Complete Fissures

The selected lobe must have an intact fissure separation with the ipsilateral lobe.3

The Spiration Valve has been demonstrated to enable significant lobar reduction in select patients.2,6 Lobar volume reduction is most pronounced and clinically beneficial in patients where the targeted lobe is isolated from collateral ventilation through complete fissures.1,2,3,8

Quantitative Analysis Strategies:

Fissures may be visually estimated to be intact if it is ≥ 90% complete after viewing the HRCT in three dimensions (sagittal, axial, and coronal).3,8

Automated methods to provide exact quantifications and support visual readings may also be used.1,8

2. Severe Emphysema

The lobe with the greatest amount of emphysema destruction should be evaluated first. If that lobe does not meet subsequent criteria, consider the second most diseased lobe.3

The Spiration Valve System has received market clearance in select countries to treat severely diseased lung in patients with heterogeneous emphysema with evidence or markers of low collateral ventilation such as complete fissures, or damaged lung resulting in air leaks, by limiting airflow to selected areas.